A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified November 2011 by Cyclacel Pharmaceuticals, Inc.
Sponsor:
Cyclacel Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00885963
First received: March 31, 2009
Last updated: November 7, 2011
Last verified: November 2011
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Purpose
This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: sapacitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Cyclacel Pharmaceuticals, Inc.:
Primary Outcome Measures:
- the rate of response and stable disease [ Time Frame: after cycle 2, 4, 7 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression-free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- duration of response [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- duration of stable disease [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: sapacitabine |
Drug: sapacitabine
twice daily by mouth for 7 days or once daily by mouth for 5 days/week x 2 weeks every 21 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed recurrent NSCLC
- Age of 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to RECIST
- Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
- At least 3 weeks from major surgery
- Patient must be able to swallow capsules
- Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
- NSCLC histology contains a component of small cell lung cancer
- Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
- Pregnant or lactating women
- Known to be HIV-positive
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885963
Locations
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Philip Bonomi, M.D. 312-942-3192 | |
| Contact: Deborah Pach, RN 312-563-3347 | |
| Principal Investigator: Philip Bonomi, M.D. | |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Rebecca Miller, RN 717-531-1003 | |
| Principal Investigator: Chandra Belani, M.D. | |
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
| Study Chair: | Philip Bonomi, M.D. | Rush University Medical Center |
More Information
No publications provided
| Responsible Party: | Cyclacel Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00885963 History of Changes |
| Other Study ID Numbers: | CYC682-08 |
| Study First Received: | March 31, 2009 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013